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Q&A: With New EU Regs Taking Effect, What Can Industry Do To Be Proactive?

The new EU Medical Device and IVD Regulations will be published any day and take effect within weeks. In this interview, John Brennan, outgoing regulations chief for Medtech Europe, tells Medtech Insight what the European Commission, competent authorities and industry should do now to avoid obstacles.

Regulation Medical Device Europe

Advent Of Artificial Pancreas Tech To Galvanize Fast-Growing Diabetes Market

The global diabetes management devices market is expected to exceed $11.2bn by 2020, driven largely by the rising diabetes epidemic. This, in turn, is fueling significant innovation such as next-generation, automated artificial pancreas systems and miniaturized, less-invasive wireless technologies that can continuously track and analyze glucose levels in real-time. This feature looks more closely at these and other potentially groundbreaking new technologies, as well as the competitive landscape of the two major product segments – insulin pumps and blood glucose monitors.

Diabetic Care Metabolic Commercial

Practicing What It Preaches: US FDA Device Center To Build Its Own Quality System, Become ISO 9001 Compliant

The head of the Center for Devices and Radiological Health's compliance office says it wants to be in the "tent together" with medical device manufacturers by creating a quality system for its own internal operations that will be based on the standard from the International Organization for Standardization.

Quality Control FDA Compliance

Device Week – April 28, 2017

On this week's Medtech Insight podcast: four companies highlighted at a London event showcasing new health-care technology and medical device start-ups; US FDA's device center looks to build a quality system and plans to shuffle staff under a "Total Product Life Cycle" initiative; the latest on legislative efforts around the classification of device accessories; BD acquires CR Bard for $24bn; a spotlight on the growth of the diabetes management devices market; and more.

Medical Device Quality Control Deals
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Policy & Regulation Explore this Topic

Set Alert for Policy

Webinar: What's Ahead For IVD Regulations In The EU And US

In this hour-long webinar, Medtech Insight's Amanda Maxwell and David Filmore, and In Vivo's Ashley Yeo discuss regulatory reforms in the works for in vitro diagnostics in the EU and US.

In Vitro Diagnostics Regulation Europe

Gottlieb Wants Timely Approval Of User Fee Bill, Balanced LDT Plan

FDA Commissioner-nominee Scott Gottlieb was approved by the Senate HELP committee April 27, sending his confirmation to the full Senate. Written responses from Gottlieb to senators' questions provided in advance of the vote don't hold any big surprises, but they provide a view into priorities of the incoming official and the lawmakers, including quick user-fee reauthorization, resolving the lab-developed test oversight debate, off-label and "right-to-try" issues and post-market surveillance.

Policy Leadership Legislation

Sen. Klobuchar Forming Coalition To Push For Both Device, Cadillac Tax Repeal

Sen. Amy Klobuchar, D-Minn., is putting together a coalition of lawmakers who favor repeal of both the medical device excise tax and the Affordable Care Act's so-called "Cadillac tax" on high-expense health-care plans.

Legislation United States

New Bill Would Regulate Third-Party Device Servicers

A new House bill seeks to even the playing field so that third-party service providers are subject to similar FDA oversight to what manufacturers face when servicing their own devices.

Legislation Regulation

Canada Introduces World's First 48-Hour Reporting Requirement

New regulations in Canada could mean companies are required to notify the country's regulator more quickly about foreign-risk communications and conduct new post-marketing safety tests.

Canada Regulation

Calif. Jury Awards $25m In Device-Maker Whistleblower Case

A former sales manager said the vascular device company first cut his compensation and then fired him after he reported a promotional scheme implemented by his supervisor that violated anti-kickback law and could pose a risk to patient safety.

Legal Issues Medical Device

Legislation Would Streamline Risk-Classification For Device Accessories

A bill introduced in the US that industry stakeholders want to be added to the "must-pass" user-fee reauthorization bill would create a tailored approach to classifying or reclassifying device accessories, following up on change made last year that requires accessories to be classified separately from parent devices. Streamlining accessory oversight has been an industry goal, particularly of health-software makers.

Digital Health Legislation

US FDA Still Waiting For Cures Money, Woodcock Says

When asked about Cures-related hiring, the FDA drug-center director says to her knowledge, no funding has been received yet.

FDA Policy

Quality Control Explore this Topic

Latest From Quality Control

Snapshot: Device Recalls Tick Up Only 1% In 2016 Despite Midyear Surge

A count of fiscal year 2016 recalls provided by the agency shows that there were 43 high-risk class I (4%), 1,090 class II (92%) and 50 class III (4%) recalls last year, up a mere percentage point from the prior year. Device-makers had been on pace for a more modest number of corrections and removals for 2016, but a sudden mid-calendar-year spike in recalls caused the total to jump significantly.

Recalls Compliance

Medtronic StratMR Device Gets Class I Recall

Following a voluntary recall from Medtronic of its StratMR adjustable valves and shunts, US FDA has issued the highest level of recall for the devices, stating they could severely injure patients or cause death.

Recalls Safety

US FDA Device Center Pushes 'Total Product Life Cycle' Concept; 'Reorganization' Coming, Says Compliance Chief

The Center for Devices and Radiological Health is shaking up how its pre- and post-market specialists interact under a new "Total Product Life Cycle" scheme.

Life Cycle Management Quality Control

Commercial Explore this Topic

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Emerging Markets Welcome Rise Of Robots, But UK Skeptical

New research from Pricewaterhouse Coopers finds that emerging economies are more willing to embrace the use of AI and robotics in health care, compared to Western European countries. The report – "What Doctor? Why AI and Robotics Will Define New Health" – surveyed more than 11,000 people from 12 countries across Europe, the Middle East and Africa. Among these countries, the UK proved to be the biggest skeptic.

Innovation Market Access Commercial

Latest From Commercial

Medical Device Startups Shine At AXA PPP Health Tech & You Awards

Medtech Insight met with finalists of the AXA PPP Health Tech & You 2017 awards at the Design Museum to find out more on the latest healthcare innovations. Some of the technologies showcased included a home monitoring blood count monitoring device for cancer patients and the first Class 1 medical device smart phone app.

Commercial Companies

Stent Leaders Pull Out Of India Amidst Price Cap Storm; Opportunity For 'The Dragon'?

The storm in India over price caps on stents has not shown any signs of abating, with foreign firms seeking to pull back certain key brands and the pricing regulator resolute about maintaining market equilibrium. The slugfest also appears to have opened up the Indian market for Chinese firms, among others.

India Cardiovascular

BD, CR Bard Merger To Create Vascular Access Device Giant

Becton Dickinson has reached a definitive agreement to acquire CR Bard for $24bn. BD says Bard's product portfolio gives it a strong presence in fast-growing clinical areas and more reach outside the US while Bard expects to reach more customers by building on BD's leadership in medication management and infection prevention.

Companies Commercial

Nanjing BioPoint Shoots For 2018 Double POC Launch; Seeks $10m

A China-based IVD company, spun out of an Australian medical research institute, is seeking investors to support its plans for the 2018 launch its first two point-of-care tests for patients with infectious diseases including HIV and viral hepatitis.

In Vitro Diagnostics Financing

Device Week – April 21, 2017

On this week's Medtech Insight podcast we highlight two big M&A deals: Abbott & Alere, and Medtronic & Cardinal Health.

Commercial Deals

STAT-DX Aims To Take On Rival BioFire In Syndromic Testing

Barcelona start-up STAT-DX is gearing up to launch a new decentralized multiplex PCR system in the rapidly growing field of syndromic testing. The company, which will face larger rivals such as bioMérieux's BioFire, will unveil its new point-of-care platform at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), in Vienna from 22-25 April.

Infectious Diseases In Vitro Diagnostics

Clinical R&D Explore this Topic

Set Alert for Clinical R

Starts & Stops: ICS' Emblok Medtronic's Arctic Front, Abbott's Absorb, Boston Scientific's S-ICD

Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial initiations, completions and suspensions each month. Over the last month, 31 new trials started, 25 trial were completed, one trial was "reinitiated," and six trials were terminated or suspended, according to meddevicetracker.

Clinical Trials Research & Development Starts & Stops

Latest From Research & Development

A New NEST: MDIC Leaders Discuss Relocation, National Evaluation System And More

Medical Device Innovation Consortium's CEO William Murray and VP for Technology Innovation Dawn Bardot sat down with Medtech Insight during the recent Design of Medical Devices conference in Minneapolis to discuss what their organization has been doing lately and some future focuses in the areas of regulatory science and device data collection.

Research & Development Innovation

Start-Up Spotlight: Amniox Medical, Bringing The Benefits Of Amniotic Tissue To Ortho And Wound Care

Amniox Medical is developing biologics products for wound-healing and orthopedic applications based on technology that takes advantage of the unique anti-inflammatory and anti-scarring properties of human amniotic membrane and umbilical cord matrix.

Regenerative Medicine Wound Healing & Tissue Repair

Edwards Gets Early Present With FDA Clearance

While Edwards Lifesciences was hoping for a 510(k) clearance later in the year, the company got the greenlight to market its new hemodynamic monitoring system, HemoSphere, in the first quarter.

Cardiovascular Cardiology

ElectroCore's gammaCore Gets US Clearance For Cluster Headaches

The de novo clearance is the first US clearance for electroCore's non-invasive vagus nerve stimulation therapy. The company will market it through headache specialists as a non-pharmacological alternative to sumatriptan for patients with cluster headaches, which afflict about 350,000 people in the US.

Neurology Innovation

Device Debuts: Tryton, Myriad Genetics, Integra Lifesciences, Acelity, And Toyota

This edition of device debuts highlights a wide variety of innovative devices introduced into commercial markets since the beginning of March, including a new stent for side-branch coronary interventions, an assay that identifies which breast-cancer patients do not need chemotherapy, a full ankle prosthesis, improvements to a negative-pressure wound therapy system, and a robotic system that helps paralyzed people learn to walk again.

Research & Development Clinical Trials

Game On For Akili's Cognitive Control Tech

A digital video game developed by Akili Interactive Labs for treating cognitive disorders has demonstrated in a pilot study its ability to improve cognitive control test scores of neurotypical children and children with sensory processing dysfunction (SPD). The company is also anticipating a market launch of the device for pediatric attention deficit hyperactivity disorder in 2018.

Digital Health Neurology
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